BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2880976 · Received December 14, 2012

    Report

    Report Number
    2028159-2012-02000
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 15, 2012
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE QUESTIONNAIRE WAS RECEIVED AND REVIEWED BY THE ALCON CLINICAL ANALYST, WHO STATED: THE CUSTOMER REPORTED A TASS EVENT. THE VOLUME OF WATER USED TO FLUSH HANDPIECES (60 ML) IS INADEQUATE. THE HANDPIECE DIRECTIONS FOR USE (DFU) STATES A MINIMUM OF 120 ML PER PORT IS REQUIRED FOLLOWED BY 60 CC OF AIR. BASED ON REVIEW OF THE COMPLAINT DATA, THE INSUFFICIENT FLUSHING VOLUME DESCRIBED IN THE RETURNED FACILITY QUESTIONNAIRE MAY BE A CONTRIBUTING FACTOR TO THE REPORTED EVENT. IT IS RECOMMENDED THAT THE FACILITY BE MADE AWARE OF THE CORRECT FLUSHING VOLUMES AS NOTED IN THE HANDPIECE DFU. THE FACILITY DID NOT REQUEST SERVICE. THERE WAS NO SAMPLE RETURNED FOR EVALUATION AND NO ADDITIONAL INFORMATION PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID INDICATE 2 SIMILAR REPORT(S) FOR PHACO HANDPIECE. THE PROPER CLEANING AND STERILIZATION OF OPHTHALMIC SURGICAL INSTRUMENTS CAN HELP PREVENT THE OCCURRENCE OF TASS. THESE FINDINGS CONTINUE TO VALIDATE THE NEED TO FOLLOW THE RECOMMENDATIONS DETAILED IN THE DFUS, ASORN RECOMMENDED PRACTICES, AND THE ASCRS TASS TASK FORCE GUIDANCE DOCUMENT. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED TO BE RELATED TO AN ALCON PRODUCT. (B)(4).

    Description of Event or Problem · 1

    A DIRECTOR REPORTED ONE DAY POSTOPERATIVE TASS (TOXIC ANTERIOR SEGMENT SYNDROME). ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON WHO REPORTED THE PATIENT PRESENTED WITH PHOTOPHOBIA AND IRITIS FOLLOWING CATARACT SURGERY. THE OUTCOME AND PROGNOSIS OF THE EVENT IS UNKNOWN. IN THE OPINION OF THE SURGEON, IT IS UNKNOWN WHETHER THE DEVICE CONTRIBUTED TO THE EVENT. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR PATIENT 3 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other CYCLOPENTOLATE 1%| VANTAGE BASIC CUSTOM EYE PACK| OZIL TORSIONAL PHACO HANDPIECE| 45 DEG. KELMAN .9MM ABS MINI TIP| DUOVISC| DIFLUPREDNATE| 1.0MM DOUBLE BEVEL SIDEPORT BLADE| BALANCED SALT SOLUTION (15ML AND 500ML)| .3MM POLYMER 35 DEG BENT IRRIGATION ASPIRATION TIP| NON-ALCON 27 GAUGE "J" SHAPED CANNULA| MONARCH III "D" CARTRIDGES| ACRYSERT DELIVERY SYSTEM| 2.0 SB CLEARCUT SLIT KNIFE| BETADINE OPHTHALMIC PREP| OPHTHALMIC INCISE DRAPE| PHENYLEPHRINE 10%| BROMFENAC| BESIFLOXACIN| NON-ALCON 25 GAUGE HYDRODISSECTION CANNULA| INTREPID PLUS FMS BASIC| FLURBIPROFEN 0.03%| .9MM MICROSMOOTH NANO INFUSION SLEEVE KIT| NON-ALCON 25 GAUGE FORMED CYSTOTOME| SN60WF 22.0 DIOPTER IOL| GATIFLOXACIN 0.5%